M
medi12
Hi all,
Does somebody know how device changes (minor and major) to registered medical devices must be handled in Malaysia? Is a new registration/approval necessary? Maybe there exists a similar guidances as the "Deciding when to submit a 510k for a change to an existing device" guidance of the FDA but I was not able to find it.
Best Regards.
Does somebody know how device changes (minor and major) to registered medical devices must be handled in Malaysia? Is a new registration/approval necessary? Maybe there exists a similar guidances as the "Deciding when to submit a 510k for a change to an existing device" guidance of the FDA but I was not able to find it.
Best Regards.